510(k) · Cleared
ClearedPotable Air Massager Putifino, Model AM-7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Seimitsu Sokki Co., Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Feb 15, 2008 as substantially equivalent to K050697 (Nihon Seimitsu Sokki Co., Ltd., 2005) and 1 other predicate after a 248-day review. Its family tree reaches back 3 generations to 1985. 55 later devices descend from it.
- Decided
- Feb 15, 2008
- Review
- 248 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K850316 (1985). 4 ancestors in all. 55 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 2 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 1 generation backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- This deviceK071596 Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008
- Descendant · cites it directly · 54 of its ownK092435 Verseo Air Pressure MassagerThe American Export Group & International Services · 2010
- Descendant · cites it directly · 53 of its ownK122154 Powerplay Muscle MassagerFig, LLC · 2012
- Descendant · 2 generations on · 51 of its ownK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
- Descendant · 3 generations on · 38 of its ownK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
- Descendant · 3 generations on · 20 of its ownK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K092435Verseo Air Pressure MassagerThe American Export Group & International Services · 2010 · cites it directly54descendants
- K122154Powerplay Muscle MassagerFig, LLC · 2012 · cites it directly53descendants
- K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016 · 2 generations on51descendants
- K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018 · 3 generations on38descendants
- K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −2 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −1 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| 0 (this device) | K071596 | Potable Air Massager Putifino, Model AM-7 | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| +1 | K092435 | Verseo Air Pressure Massager | The American Export Group & International Services | 2010 | — |
| +1 | K122154 | Powerplay Muscle Massager | Fig, LLC | 2012 | — |
| +2 | K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016 | — |
| +3 | K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC | 2018 | — |
| +3 | K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 12 | 0 |
| 2022 | 11 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IRP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IRP device
- #1 K193354 Air Compression Therapy Devicescore 28.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050697 | Model DS-1901 Digital Blood Pressure MonitorSummary page 1…ered inflatable tube massager 6. Predicate Device Manufacturer :Salton, Inc Trade Name :Relaxor Perfect Touch Air Massaging System 510(k) No : K050697, Cleared on April 10, 2003 7. Description of Device Portable Air Massager putifino AM-7 is a powered inflatable tube massager… | 2005 |
| * | K030437 | Relaxor Perfect Touch Air Massaging SystemSummary page 3…5-2 Appendix 1: Comparison Table with Predicate Device SUBJECT DEVICE:AM-7 PREDICATE DEVICE:K030437 INDICATION FOR USE INDICATION FOR USE The Portable Air Massager putifino AM-7 is The Perfect Tou… | 2003 |
What descends from it? (55)
See all 552 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 1 company; a new generation was cleared every 5.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K092435 (The American Export Group & International Services, 2010) has gone furthest, with 54 descendants of its own.
- 1 other device also cites its predicate K050697.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IRP
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IRP
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IRP
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IRP
10in 2025
MAUDE reports naming product code IRP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 5 |
| 2011 | 3 | 164 | 1 | 3 |
| 2012 | 5 | 116 | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 113 | 0 | 0 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 4 | 170 | 2 | 0 |
| 2018 | 3 | 80 | 0 | 0 |
| 2019 | 10 | 83 | 0 | 0 |
| 2020 | 9 | 150 | 0 | 1 |
| 2021 | 19 | 140 | 0 | 0 |
| 2022 | 14 | 97 | 0 | 1 |
| 2023 | 10 | 143 | 0 | 0 |
| 2024 | 12 | 115 | 0 | 4 |
| 2025 | 13 | 141 | 0 | 10 |
| 2026 | 12 | 172 | 0 | — |
What is it indicated for?
The Portable Air Massager putifino AM-7 is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Portable Air Massager putifino AM-7 simulates kneading and stroking of tissues by using an inflatable garment (Cuff).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071596: Potable Air Massager Putifino, Model AM-7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071596
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026